Medical Policy

Policy Num:      07.001.088
Policy Name:    Lung Volume Reduction Surgery for Severe Emphysema
Policy ID:          [7.001.088]  [Ac / B / M+ / P+]  [7.01.71]

Last Review:   July 17, 2024
Next Review:   July 20, 2025
 

Related Policies:

07.001.082 - Bronchial Valves
08.003.002- Outpatient Pulmonary Rehabilitation 

Lung Volume Reduction Surgery for Severe Emphysema

summary

Description

Lung volume reduction surgery (LVRS) is proposed as a treatment option for patients with severe emphysema who have failed optimal medical management. The procedure involves the excision of diseased lung tissue to reduce symptoms and improve quality of life.

Summary of Evidence

For individuals who have upper-lobe emphysema who receive lung volume reduction surgery (LVRS), the evidence includes randomized controlled trials (RCTs) and systematic reviews of the trials. Relevant outcomes are OS, symptoms, functional outcomes, quality of life, and treatment-related mortality. Findings from the National Emphysema Treatment Trial (NETT), a multicenter RCT, have suggested that LVRS is effective at reducing mortality and improving quality of life in select patients with severe emphysema. In a subgroup analysis, LVRS offered a survival advantage only to patients not considered at high-risk who had predominately upper-lobe emphysema and low initial exercise capacity. Patients with upper-lobe emphysema, regardless of initial exercise capacity, experienced significant improvement in exercise capacity and quality of life after LVRS. Other, smaller RCTs have generally had similar findings, though they have tended to be underpowered for some outcomes and did not stratify by the distribution of emphysema. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have non-upper-lobe emphysema who receive LVRS, the evidence includes a subgroup analysis of a large RCT. Relevant outcomes are OS, symptoms, functional outcomes, quality of life, and treatment-related mortality. In the subgroup analysis of the NETT, LVRS offered a survival advantage only to patients who had predominately upper-lobe emphysema. For the subgroup with predominately non-upper-lobe emphysema, the NETT did not find significant mortality advantages or symptom improvement with LVRS. Although the NETT had positive findings for the study population as a whole, given the surgical risks, additional data are needed to confirm the net health outcome in patients with non-upper-lobe emphysema. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable.

OBJECTIVE

The objective of this evidence review is to determine whether lung volume reduction surgery improves the net health outcome in individuals with emphysema.

POLICY

Lung volume reduction surgery as a treatment for emphysema may be considered medically necessary in individuals who meet all of the following criteria^a:

• Predominately upper-lobe emphysema with hyperinflation and heterogeneity (ie, target areas for removal);

• Forced expiratory volume in 1 second (FEV₁):

  • For individuals who are younger than 70 years of age, FEV₁ must be no more than 45% of the predicted value;

  • For individuals who are 70 years of age or older, FEV₁ must be no more than 45% of the predicted value and 15% or more of the predicted value.

• Marked restriction in activities of daily living, despite maximal medical therapy;

• Age younger than 75 years;

• Acceptable nutrition status (ie, 70% to 130% of ideal body weight);

• Ability to participate in a vigorous pulmonary rehabilitation program;

• No coexisting major medical problems that would significantly increase operative risk;

• Willingness to undertake the risk of morbidity and mortality associated with lung volume reduction surgery;

• Abstinence from cigarette smoking for at least 4 months.

Lung volume reduction surgery is considered investigational in all other individuals.

The following additional criteria, also from the National Emphysema Treatment Trial, may further refine the selection of an individual who is a candidate for lung volume reduction surgery (LVRS):

• Arterial partial pressure of oxygen on room air of 45 mm Hg or more (≥30 mm Hg at elevations of ≥5000 feet [1524 meters])

• Arterial partial pressure of carbon dioxide on room air less than or equal to 60 mm Hg (≤55 mm Hg at elevations of ≥5000 feet [1524 meters])

• Post rehabilitation 6-minute walk distance of at least 140 meters, and ability to complete 3 minutes of unloaded pedaling in an exercise tolerance test.

Coding

See the Codes table for details.

BENEFIT APPLICATION

BlueCard/National Account Issues

Lung volume reduction surgery is a complex procedure, and replication of the positive results reported in the National Emphysema Treatment Trial may only be achieved by institutions experienced in this surgery.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

Emphysema

Emphysema is an anatomically defined condition characterized by the destruction and enlargement of lung alveoli. It is 1 of the conditions considered as a chronic obstructive pulmonary disease (COPD) along with chronic bronchitis and small airway disease. The pathogenesis of emphysema is primarily related to cigarette smoking leading to inflammation and recruitment of immune cells to the terminal air spaces of the lung. The resultant extracellular matrix proteolysis damages the lung. Destruction of the gas-exchanging air spaces and ineffective repair of the extracellular matrix results in airspace enlargement. Emphysema can be characterized into distinct pathologic subtypes. Centriacinar emphysema is most frequently associated with cigarette smoking, is usually most prominent in the upper lobes and superior segments of the lower lobes, and is focal. Panacinar emphysema is characterized by abnormally large air spaces evenly distributed across acini in the lower lobes. It is associated with α₁-antitrypsin deficiency. Key pulmonary function parameters are the volume of the first forced expiratory volume in 1 second (FEV₁) and the total volume of air exhaled during the spirometry (forced vital capacity [FVC]). Airflow obstruction related to COPD is characterized by the reduced ratio of FEV₁/FVC, and reduction in FEV₁ correlates with long-term mortality risk.^1,

The 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) report states that COPD is 1 of the top 3 causes of death globally and 90% of these deaths occur in low- and middle-income countries.^2, Evidence exists that the prevalence of the disease is appreciably higher in smokers and ex-smokers compared to non-smokers, in those ≥40 years of age compared to those <40, and in men compared to women; although, in developed countries with less smoking, the prevalence is approximately equal between men and women. The COPD Genetic Epidemiology (COPDGene®) study aimed to determine the influence of race, gender, and GOLD stage on the prevalence of prior COPD diagnosis at enrollment.^3, Results revealed that African-American individuals had increased odds of not having a prior COPD diagnosis at all GOLD stages of airflow obstruction versus non-Hispanic White individuals (p<.0001). Women had higher odds of having a prior COPD diagnosis at all GOLD stages versus men (p<.0001).

Lung Volume Reduction Surgery

Lung volume reduction is a surgical treatment for patients with severe emphysema. The procedure involves the excision of peripheral emphysematous lung tissue, generally from both upper lobes.

The mechanism of clinical improvement for patients undergoing lung reduction surgery has not been firmly established. However, it is believed that mechanical factors such as elastic recoil and diaphragmatic function are improved by reducing the volume of the hyperinflated diseased lung. In addition to changes in the chest wall and respiratory mechanics, the surgery is purported to correct ventilation-perfusion mismatch and improve right ventricular filling.

Complications from the surgical procedure include death, reintubation, arrhythmias, mechanical ventilation for more than 2 days, pneumonia, wound infection, and persistent air leak.

Research on lung volume reduction surgery has focused on defining the subgroup of patients most likely to benefit from the procedure. Potential benefits of the procedure (eg, improvement in functional capacity and quality of life) must be weighed against the potential risks of the procedure (eg, the risk of postoperative mortality).

A related policy, 7.01.128, evaluates the use of endobronchial valves for patients with severe or advanced emphysema. During this procedure, a one-way valve is inserted into the most diseased lobe of the lung, allowing air to escape but preventing its re-entry. This process results in volume reduction of the treated lobe, potentially improving lung function and quality of life for selected patients.

Regulatory Status

Lung volume reduction surgery is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

RATIONALE

The evidence review was created in July 1999. This review was archived from 2005 to 2010, following the 2003 publication of the National Emphysema Treatment Trial (NETT) findings. In 2010, the evidence review returned to active status and has been regularly updated with searches of the PubMed database. The most recent literature update was performed through March 25, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Lung Volume Reduction Surgery

Evidence for this review consists of trials that include individuals with and without upper-lobe emphysema. Results were presented for the population as a whole and subgroups of patients. While separate recommendations are provided for each subgroup of patients, all evidence is discussed in this single section.

Clinical Context and Therapy Purpose

The purpose of lung volume reduction surgery (LVRS) is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with upper-lobe emphysema and non-upper-lobe emphysema.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with upper-lobe emphysema and non-upper-lobe emphysema who have poor control of their condition through medical therapy.

Interventions

The therapy being considered is LVRS.

LVRS is proposed as a treatment option for patients with severe emphysema who have failed optimal medical management. The procedure involves the excision of diseased lung tissue to reduce symptoms and improve quality of life. LVRS can be performed through various approaches, including median sternotomy, thoracotomy, video-assisted thoracoscopic surgery (VATS), or robotic-assisted thoracoscopic surgery, depending on factors such as the extent and distribution of the diseased lung tissue, patient characteristics, and surgeon preference.

Comparators

Comparators of interest include medical management, which includes bronchodilators to relax constricted airways to relieve coughing, shortness of breath, and breathing problems; inhaled corticosteroids to reduce inflammation; and antibiotics to rid bacterial infections such as bronchitis or pneumonia.

Outcomes

The general outcomes of interest are overall survival (OS), symptoms, functional outcomes, quality of life, and treatment-related mortality. Emphysema cannot be cured. The goal of LVRS is to relieve symptoms (eg, improve dyspnea and oxygenation) and slow the progression of the disease, thereby improving quality of life.

Potential harmful outcomes are related to procedural complications including death, reintubation, arrhythmias, mechanical ventilation for more than 2 days, pneumonia, and persistent air leak.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Randomized Controlled Trials

National Emphysema Treatment Trial

The National Emphysema Treatment Trial (NETT) was a large, multicenter, prospective RCT comparing LVRS with optimal medical therapy in patients with severe emphysema. Two-year findings were published by Fishman et al (2003).^4, The trial included 1218 patients, and the analysis was an intention-to-treat (ITT), reporting on outcomes for all randomized patients. Enrolled individuals had a median age of 66 years. Over 90% of enrollees were non-Hispanic White individuals in both groups, with non-Hispanic Black individuals a minority of enrollees (3% vs. 4% in the surgery vs. medical therapy groups, respectively). Men comprised approximately 60% of subjects in both treatment groups. The primary outcomes included total, 30-day, and 90-day mortality, and maximal exercise capacity. Secondary outcomes included pulmonary function, distance walked in 6 minutes, self-reported health-related quality of life, and general quality of life. At a preliminary analysis, 371 (30%) patients had been followed for a total of 24 months. The primary findings of the Fishman et al (2003) study are summarized in Table 1.

Table 1. National Emphysema Treatment Trial Primary Findings

Conclusions drawn from these data include the following:

• Overall, LVRS increased the chance of improved exercise capacity but did not confer a survival advantage over medical therapy.

• There was a survival benefit for those patients who had both predominately upper-lobe emphysema and low baseline exercise capacity. This survival advantage appears to be due to the very high mortality and marked progressive functional limitation of those treated medically.

• Patients considered at high-risk and those with non-upper-lobe emphysema and high baseline exercise capacity were found to be poor candidates for LVRS.

A follow-up analysis of NETT data was published by Naunheim et al (2006), who reported a median follow-up of 4.3 years compared with 2.4 years in the initial full report.^5, Seventy percent of randomized patients participated in the follow-up extension conducted in 2003, and 76% participated in the mailed quality-of-life data collection in 2004. The analysis was done on an ITT basis, including all 1218 randomized patients.

Overall, LVRS showed a mortality benefit compared with medical therapy. During follow-up, 46.5% (283/608) of patients in the LVRS group and 53.1% (324/610) of patients in the medical therapy group died (relative risk [RR], 0.85; p=.02). However, the long-term mortality benefit was limited to the subgroup of participants who had predominately upper-lobe emphysema and low exercise capacity (those found in the initial report to benefit from LVRS; RR, 0.57; p=.01). Moreover, in the subgroup of patients with predominately upper-lobe emphysema and low exercise capacity (n=290), compared with medical therapy, those in the LVRS group were also more likely to have improved exercise capacity throughout 3 years of follow-up testing (p<.01) and to have an 8-point improvement in quality of life through 4 years of follow-up testing (p=.003).

In the subgroup of patients with predominately upper-lobe emphysema and high exercise capacity (n=419), there was no survival benefit associated with LVRS, but there was a significantly greater improvement in exercise capacity over 3 years (p<.001) and quality of life over 4 years (p=.003). Patients with non-upper-lobe emphysema and either high or low exercise capacity did not significantly benefit from surgery with respect to mortality rates, exercise capacity, or quality of life. A limitation of the long-term follow-up study was that fewer than 80% of surviving NETT participants took part.

Sanchez et al (2010) analyzed data from the NETT, focusing on patients who met the following criteria: (1) predominately upper-lobe emphysema and (2) a heterogeneous distribution of emphysema (non-upper-lobe emphysema) defined as a difference of at least 2 points in the severity of emphysema in any 2 zones of the lung on a 0-to-4 severity scale.^6, Of the 1218 patients enrolled in the study, 511 (42%) patients met both criteria, 261 in the LVRS group and 250 in the medical therapy group. Using Kaplan-Meier analysis, the 3-year survival rate was 81% for patients receiving LVRS and 74% for those in the medical group (p=.05). At 5 years, the estimated survival rate was significantly higher in the LVRS group (70%) compared with the medical therapy group (60%; p=.02). Maximal exercise capacity (another NETT primary outcome) was a mean of 49 watts in the LVRS group and 38 watts in the medical therapy group at 1 year (p<.001). At 3 years, exercise capacity in the 2 groups was 43 watts and 38 watts, respectively, and the between-group difference was not statistically significant.

Kaplan et al (2014) reported on long-term outcomes for high-risk patients from the NETT.^7, In this subgroup of 140 randomized patients, the mortality rate was higher in the LVRS group than in the medical therapy group for the first 4.4 years, but longer-term survival did not differ significantly between the 2 groups. Median survival was 2.14 years (95% confidence interval [CI], 1.20 to 4.07 years) in the LVRS group and 3.12 years (95% CI, 2.79 to 4.27 years) in the medical therapy group (p>.05).

Lim et al reevaluated the results from NETT using longitudinal data methodology to report longer-term outcomes.^8, At 5 years, patients who received LVRS versus medical treatment had sustained improvements (measured as % of predicted value) in FEV₁ (+1.47%; p<.001), FVC (+3.44%; p<.001), and residual volume (-19.49%; p<.001). Furthermore, patients who received LVRS versus medical treatment had non-statistically significant improvements in maximum workload (+0.89 watt; p=.069) and quality of well-being score (+0.088; p=.102).

Randomized Controlled Trials Other Than The National Emphysema Treatment Trial

Miller et al (2006) published a trial evaluating data from 5 centers in Canada (Canadian Lung Volume Reduction Surgery trial).^9, Eligibility criteria included: age between 40 and 79 years; disabling dyspnea; forced expiratory volume in 1 second (FEV₁) of no more than 40% of predicted; diffusing capacity no more than 60%; and total lung capacity no more than 120% or residual volume no less than 200%. After eligibility screening, medical therapy was optimized, and patients were randomized to LVRS (n=32) or continued medical therapy (n=30). The trialists had originally planned to enroll 350 subjects, but due to the low proportion of screened subjects who were eligible, recruitment stopped at only 18% (62/467) of the target. Based on ITT analysis, the overall 2-year survival rate was similar between groups: 5 (16%) of 32 patients died in the LVRS group, and 4 (13%) of 30 died in the medical therapy group (p=.93). At 3 and 6 months, there were significantly greater improvements from baseline in FEV₁ for the LVRS group compared with the medical therapy group, but the between-group differences in FEV₁ were not significant at 12 and 24 months. This study might have been underpowered to detect differences in outcomes between groups.

Agzarian et al (2013) published long-term results of the Canadian Lung Volume Reduction Surgery trial.^10, Fifty-two (84%) of 62 randomized patients were available for follow-up 8 to 10 years post treatment. One patient was excluded before surgery, and 9 others were lost to follow-up. The proportion of patients surviving 5 and 10 years were 46% and 7%, respectively, in the LVRS group and 25% and 0% in the control group. According to Kaplan-Meier survival analysis, median survival was 63 months in the LVRS group and 47 months in the control group (p=.20).

Systematic Reviews

In a systematic review, Huang et al (2011) pooled analyses of patients undergoing LVRS for severe emphysema.^11, Eight RCTs (N=1677) published from 1999 to 2010 were included in the analysis. Reviewers found significantly higher odds of mortality in the medical therapy group than in the LVRS group at 3 months (odds ratio [OR], 5.16; 95% CI, 2.84 to 9.35). They found no statistically significant difference between groups in the mortality rate at 12 months (OR, 1.05; 95% CI, 0.82 to 1.33).

A 2016 Cochrane review, updating the 2006 meta-analysis, compared the effectiveness of LVRS with standard nonsurgical therapy in improving health outcomes for patients who had severe diffuse emphysema.^12,13, The search period for the update extended to April 2016. Two new trials, contributing 89 participants (Clarenbach et al [2015]^14, and Pompeo et al [2012]^15,), were identified and incorporated into the review along with long-term follow-up data from the Canadian Lung Volume Reduction Surgery and NETT trials. These additional data resulted in changes to the conclusions of the 2016 update. A summary of the updated results is presented in Table 2. Patients in the surgery group experienced lower overall mortality in the long-term (≥3 years), as well as significant improvements in FEV₁, quality of life, and exercise capacity compared with patients receiving only medical management. Patients with upper-lobe emphysema and low exercise capacity benefited most from the LVRS.

A total of 11 RCTs (N=1760) were included in the updated review. The NETT accounted for 68% of the review participants. The OR for surgery versus control was 0.76 (95% CI, 0.61 to 0.95).

Table 2. Systematic Review Results for Surgery versus Control

A subgroup analysis evaluated which surgical approaches for LVRS were most effective. In most trials, the decision to perform 1 technique over the other was left to the surgeon. Two of the most commonly employed surgical techniques (video-assisted thoracoscopic surgery and median sternotomy) were assessed as a randomized comparison within 1 of the studies. A small subgroup study (n=148 patients) randomized median sternotomy and video-assisted thoracoscopic surgery at several NETT centers. There were no significant differences in air leak and 30-day mortality rates between the 2 groups (p=.08 and p=.39, respectively).

Reviewers raised a concern about the validity of using the subgroup distinctions to determine which patients would be most likely to benefit from the procedure or who would be at the greatest risk of early mortality due to the low likelihood that additional studies of similar statistical power to NETT will be conducted.

Nonrandomized Comparative Studies

Decker et al (2014) reviewed data on 538 patients from the Society of Thoracic Surgeons (STS) database who received LVRS and compared these data with those of the 608 NETT participants randomized to the surgery group.^16, None of the patients in the STS database had an FEV₁ less than 20% of predicted or carbon monoxide diffusing capacity less than 20% of predicted; thus, these patients would not have been considered high-risk in the NETT. Moreover, about 10% of patients in the STS database had previous cardiothoracic surgery, and 1.5% had lung cancer, both exclusions in NETT. Overall, the mortality rate within 30 days of LVRS did not differ significantly between the STS database (5.6%) and the NETT (3.6%; p=.113). When database findings were compared with non-high-risk NETT participants, the 30-day mortality rate was significantly higher among patients in the STS database (5.6%) than in the NETT (2.2%; p=.005). This study was descriptive and did not propose patient selection criteria for LVRS.

Summary of Evidence 

With upper-lobe emphysema

For individuals who have upper-lobe emphysema who receive lung volume reduction surgery (LVRS), the evidence includes randomized controlled trials (RCTs) and systematic reviews of the trials. Relevant outcomes are OS, symptoms, functional outcomes, quality of life, and treatment-related mortality. Findings from the National Emphysema Treatment Trial (NETT), a multicenter RCT, have suggested that LVRS is effective at reducing mortality and improving quality of life in select patients with severe emphysema. In a subgroup analysis, LVRS offered a survival advantage only to patients not considered at high-risk who had predominately upper-lobe emphysema and low initial exercise capacity. Patients with upper-lobe emphysema, regardless of initial exercise capacity, experienced significant improvement in exercise capacity and quality of life after LVRS. Other, smaller RCTs have generally had similar findings, though they have tended to be underpowered for some outcomes and did not stratify by the distribution of emphysema. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

With non-upper-lobe emphysema

For individuals who have non-upper-lobe emphysema who receive LVRS, the evidence includes a subgroup analysis of a large RCT. Relevant outcomes are OS, symptoms, functional outcomes, quality of life, and treatment-related mortality. In the subgroup analysis of the NETT, LVRS offered a survival advantage only to patients who had predominately upper-lobe emphysema. For the subgroup with predominately non-upper-lobe emphysema, the NETT did not find significant mortality advantages or symptom improvement with LVRS. Although the NETT had positive findings for the study population as a whole, given the surgical risks, additional data are needed to confirm the net health outcome in patients with non-upper-lobe emphysema. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Thoracic Society and European Respiratory Society

In 2015, the American Thoracic Society and the European Respiratory Society published a joint statement on current research questions for chronic obstructive pulmonary disease.^17, The statement discussed lung volume reduction surgery (LVRS) and asserted that, due to the significant complications from the procedure that may result in prolonged hospital stays and morbidity, additional studies would be needed to evaluate minimally invasive techniques that might reduce complications.

National Institute for Health and Care Excellence

In 2005, the National Institute for Health and Care Excellence (NICE) published interventional procedures guidance on the use of LVRS for advanced emphysema.^18, The guidance suggests that LVRS for advanced emphysema appears adequate to support the use of this procedure, given the current evidence of safety and efficacy. The guidance stipulates that patient selection is important due to the mortality risk for severely compromised lung function and that the procedure should be undertaken by a team including a respiratory physician, thoracic surgeon, and specialists in pulmonary rehabilitation.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

Since November 2005, Medicare has considered LVRS reasonable and necessary for patients with severe upper-lobe-predominant emphysema or severe non-upper-lobe emphysema and low exercise capacity who meet all requirements listed in Table 3.^19,

Table 3. Medicare Criteria

A search of ClinicalTrials.gov in March 2024 did not identify any ongoing or unpublished trials that would likely influence this review.

REFERENCES

1. Jameson JL, Fauci A, Kasper DL, et al. Harrison's Principles of Internal Medicine 20th Edition. McGraw-Hill Education: Chicago, IL; 2018.
2. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2023 report. https://goldcopd.org/2023-gold-report-2/ Accessed June 21, 2023.
3. Mamary AJ, Stewart JI, Kinney GL, et al. Race and Gender Disparities are Evident in COPD Underdiagnoses Across all Severities of Measured Airflow Obstruction. Chronic Obstr Pulm Dis. Jul 02 2018; 5(3): 177-184. PMID 30584581
4. Fishman A, Martinez F, Naunheim K, et al. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. May 22 2003; 348(21): 2059-73. PMID 12759479
5. Naunheim KS, Wood DE, Mohsenifar Z, et al. Long-term follow-up of patients receiving lung-volume-reduction surgery versus medical therapy for severe emphysema by the National Emphysema Treatment Trial Research Group. Ann Thorac Surg. Aug 2006; 82(2): 431-43. PMID 16888872
6. Sanchez PG, Kucharczuk JC, Su S, et al. National Emphysema Treatment Trial redux: accentuating the positive. J Thorac Cardiovasc Surg. Sep 2010; 140(3): 564-72. PMID 20723727
7. Kaplan RM, Sun Q, Naunheim KS, et al. Long-term follow-up of high-risk patients in the National Emphysema Treatment Trial. Ann Thorac Surg. Nov 2014; 98(5): 1782-9. PMID 25201722
8. Lim E, Sousa I, Shah PL, et al. Lung Volume Reduction Surgery: Reinterpreted With Longitudinal Data Analyses Methodology. Ann Thorac Surg. May 2020; 109(5): 1496-1501. PMID 31891694
9. Miller JD, Malthaner RA, Goldsmith CH, et al. A randomized clinical trial of lung volume reduction surgery versus best medical care for patients with advanced emphysema: a two-year study from Canada. Ann Thorac Surg. Jan 2006; 81(1): 314-20; discussion 320-1. PMID 16368389
10. Agzarian J, Miller JD, Kosa SD, et al. Long-term survival analysis of the Canadian Lung Volume Reduction Surgery trial. Ann Thorac Surg. Oct 2013; 96(4): 1217-1222. PMID 23895890
11. Huang W, Wang WR, Deng B, et al. Several clinical interests regarding lung volume reduction surgery for severe emphysema: meta-analysis and systematic review of randomized controlled trials. J Cardiothorac Surg. Nov 10 2011; 6: 148. PMID 22074613
12. van Agteren JE, Carson KV, Tiong LU, et al. Lung volume reduction surgery for diffuse emphysema. Cochrane Database Syst Rev. Oct 14 2016; 10(10): CD001001. PMID 27739074
13. Tiong LU, Davies R, Gibson PG, et al. Lung volume reduction surgery for diffuse emphysema. Cochrane Database Syst Rev. Oct 18 2006; (4): CD001001. PMID 17054132
14. Clarenbach CF, Sievi NA, Brock M, et al. Lung Volume Reduction Surgery and Improvement of Endothelial Function and Blood Pressure in Patients with Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. Aug 01 2015; 192(3): 307-14. PMID 26016823
15. Pompeo E, Rogliani P, Tacconi F, et al. Randomized comparison of awake nonresectional versus nonawake resectional lung volume reduction surgery. J Thorac Cardiovasc Surg. Jan 2012; 143(1): 47-54, 54.e1. PMID 22056369
16. Decker MR, Leverson GE, Jaoude WA, et al. Lung volume reduction surgery since the National Emphysema Treatment Trial: study of Society of Thoracic Surgeons Database. J Thorac Cardiovasc Surg. Dec 2014; 148(6): 2651-8.e1. PMID 24631312
17. Celli BR, Decramer M, Wedzicha JA, et al. An official American Thoracic Society/European Respiratory Society statement: research questions in COPD. Eur Respir Rev. Jun 2015; 24(136): 159-72. PMID 26028628
18. National Institute for Health and Care Excellence (NICE). Lung volume reduction surgery for advanced emphysema [IPG114]. 2005. https://www.nice.org.uk/guidance/ipg114/ Accessed April 21, 2024.
19. Center for Medicare & Medicaid Services. National coverage determination (NCD) for lung volume reduction surgery (reduction pneumoplasty) (240.1). 2005; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=119&ncdver=3&CoverageSelection=National&KeyWord=lung+volume+reduction+surgery& KeyWordLookUp=Title&KeyWordSearchType=And&clickon=search&bc=gAAAABAAAAAAAA%3d%3d&. Accessed June 21, 2023.

Codes

Policy History